FDA proposes oral phenylephrine, found in many decongestants, pulled from shelves

The Food and Drug Administration proposed that oral phenylephrine be removed from store shelves saying that the treatment does not work.

Phenylephrine is found in over-the-counter decongestants such as Sudafed PE, Vicks DayQuil and Mucinex Sinus-Max, CNN reported.

The FDA approved phenylephrine in the 1970s but it was used in more products in 2005 after pseudoephedrine was forced to be sold from behind pharmacy counters but without a prescription. Pseudoephedrine in large quantities can be used to make methamphetamine.

Last September, an FDA advisory panel determined that phenylephrine was not effective when taken in oral form. It is also used in nasal spray to help ease congestion.

“Consumers should know that a range of safe and effective drugs and other treatments is available to temporarily relieve congestion symptoms due to allergies or a common cold,” Dr. Theresa Michele, the head of the FDA division overseeing OTC medications, said, according to The Wall Street Journal.

But Scott Melville, the chief executive of the Consumer Healthcare Products Association, said, “Consumers need options for self-care, and freedom of choice for self-care is a core attribute of our nation’s health care system.” The association represents OTC-making companies, The New York Times reported.

The new proposal only affects phenylephrine taken orally and is not considered unsafe.

By issuing the proposal, the FDA is soliciting public comments on the decision, the Times reported.

Michele said companies will have to “either reformulate or remove drug products containing oral phenylephrine from the market,” if the FDA decides to remove phenylephrine, CNN reported.

The FDA said it would give companies time to adjust the medications that would be affected. The earliest it would take effect is 2026, The Wall Street Journal reported.

CVS had already decided to not sell decongestants that contained phenylephrine, The Wall Street Journal reported.

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